S-ICD® System Post Approval Study

Completed

Conditions studied: Primary Prevention of Sudden Cardiac Arrest, Secondary Prevention of Sudden Cardiac Arrest

In brief

The purpose of the S-ICD Post Approval Study is to document long term safety and effectiveness outcomes associated with the implantation of the SQ-RX pulse generator and Q-TRAK electrode in a commercial clinical setting.

Key facts

Study ID

NCT01736618

Run by

Boston Scientific Corporation

People needed

1766

Starts

2013-03-12

Expected to finish

2021-10-15

Last updated by the study team

2024-03-18

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Eligible for implantation with an S-ICD System, OR previously implanted with an S-ICD System in the S-ICD System Clinical Investigation (IDE G090013)
• AND
• Willing and able to provide written informed consent or have informed consent provided by a legal representative

You may not qualify if…

• Remaining life expectancy of less than 360 days

Where it is running

• Cardiovascular Associates of Mesa — Mesa, Arizona, United States
• Phoenix Cardiovascular Group — Phoenix, Arizona, United States
• Arizona Arrhythmia Consultants, PLC — Scottsdale, Arizona, United States
• PIMA Heart Physicians, PC — Tucson, Arizona, United States
• St. Vincent Heart Clinic Arkansas — Little Rock, Arkansas, United States
• Providence St. Joseph Medical Center — Burbank, California, United States
• Sequoia Hospital — East Palo Alto, California, United States
• Sharp Grossmont Hospital — El Cajon, California, United States
• California Heart Associates — Fountain Valley, California, United States
• University of California San Diago — La Jolla, California, United States
• University of Southern California — Los Angeles, California, United States
• Huntington Memorial Hospital/Foothill Cardiology — Pasadena, California, United States
• Sharp Memorial Hospital — San Diego, California, United States
• St. John's Health Center — Santa Monica, California, United States
• Memorial Medical Center (UCH-MHS) — Colorado Springs, Colorado, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Cardiac Arrhythmia Services, Inc — Fort Lauderdale, Florida, United States
• St. Vincent's Ambulatory Care (Jacksonville, FL) — Jacksonville, Florida, United States
• James A Haley Veterans Affairs Hospital — Tampa, Florida, United States
• University Community Hospital (Florida Hospital)/Advent Health Tampa — Tampa, Florida, United States
• Emory University — Atlanta, Georgia, United States
• University Hospital (Augusta, GA) — Augusta, Georgia, United States
• Augusta University — Augusta, Georgia, United States
• Gwinnett Medical Center — Lawrenceville, Georgia, United States
• Heart Center Research, LLC — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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